Clinical Trial: Study to Assess the Efficacy, Safety and Tolerability of Secukinumab in Japanese Subjects With Generalized Pustular Psoriasis (GPP)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Multi-center, Open Label Study of Subcutaneous Secukinumab in Prefilled Syringes as Mono- or Co-therapy to Assess the Efficacy, Safety and Tolerability up to 52 Weeks in Japanese Subjects With

Brief Summary: The purpose of this study is to assess efficacy and safety data of secukinumab in Japanese subjects with generalized pustular psoriasis (GPP). This study is expected to support the filing of secukinumab in the indication of pustular psoriasis in Japan.

Detailed Summary:
Sponsor: Novartis Pharmaceuticals

Current Primary Outcome: Propotion of subjects who experience treatment success of secukinumab at Week 16 [ Time Frame: 16 weeks ]

Treatment success is defined as "Minimally improved", "Much improved" or "Very much improved" in Clinical global impression (CGI)


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Clinically meaningful success of secukinumab at week 16 [ Time Frame: 16 weeks ]
    Clinically meaningful success is defined as follows: 1) For subjects who receive secukinumab as monotherapy: "Minimally improved", "Much improved" or "Very much improved" in CGI, 2) For subjects who receive secukimumab as co-medication together with other immunomodulatory drug: a. ONLY IF the co-medication is not meaningfully reduced: "Minimally improved", "Much improved" or "Very much improved" in CGI, b. ONLY IF the co-medication is meaningfully reduced: "No-change", "Minimally improved", "Much improved" or "Very much improved" in CGI.
  • Treatment success and the clinically meaningful success of secukinumab at Week 52 [ Time Frame: 52 weeks ]
  • CGI [ Time Frame: evert 4 weeks ]
    CGI has five categories: Very much improved, Much improved, Minimally improved, No change and Wesened.
  • Change from baseline in the total score and the category of the JDA severity index for GPP [ Time Frame: every 4 weeks ]
    JDA severity index for GPP consists of area of etythema with pustules, area of erythema (total), area of edema, fever, WBC, hsCRP and serum albumin. The total score of JDA severity index for GPP is assigned a score of 0-17 (0=best, 17=worst).
  • Change from baseline in components of the JDA severity index for GPP [ Time Frame: every 4 weeks ]
    Area of erythema with pustules, area of erythema (total), area of edema are rated as 0 to 3. Fever, WBC, hsCRP and serum albumin are rated as 0 to 2.
  • Change from baseline in observed value of components of the JDA severity index for GPP [ Time Frame: every 4 weeks ]
  • Clinical safety and tolerability of secukinumab [ Time Frame: Up to 60 weeks ]
    Clinical safety and tolerability of secukinumab as assessed by vital signs, clinical laboratory variables, ECGs, and adverse events monitoring.
  • Change from baseline in SF-36 [ Time Frame: every 4 weeks ]
    The Short Form Health Survey (SF-36) ) is a widely used and extensively studied instrument to measure health-related quality of life among healthy subjects and patients with acute and chronic conditions. It consists of eight subscales that can be scored individually: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health.
  • Change from baseline in DLQI [ Time Frame: every 4 weeks ]
    The Dermatology Life Quality Index (DLQI) is a 10-item general dermatology disability index designed to assess health-related quality of life in adult subjects with skin diseases such as eczema, psoriasis, acne, and viral warts.
  • Use of systemic co-medication to treat GPP [ Time Frame: every 4 weeks ]
    Use of systemic co-medication to treat GPP, in subjects who have active GPP treatment at baseline.
  • Use of topical co-medication to treat GPP [ Time Frame: every 4 weeks ]
    Use of topical co-medication to treat GPP, in subjects who have active GPP treatment at baseline.


Original Secondary Outcome: Same as current

Information By: Novartis

Dates:
Date Received: September 24, 2013
Date Started: August 2013
Date Completion:
Last Updated: August 2, 2016
Last Verified: August 2016